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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02159456
Other study ID # feed520
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date December 2021

Study information

Verified date August 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

1. Nutritional support during critical illness is important to improve the clinical outcome of patients. Recently, the apply of early enteral nutrition is recommend in critically ill patients on basis of data that enteral nutrition can be helpful to prevent the hospital-acquired infections. - However, in critically ill patients, the smooth progress of nutritional support is often hindered by gastrointestinal intolerance, underlying clinical condition, and temporal necessity of procedure or operation. - Continuous feeding method, compared with intermittent feeding, is expected to reduce the risk of gastrointestinal intolerance, and improve the nutritional support, but this hypothesis is not supported by appropriate evidences. 2. We will elucidate to compare the efficacy and safety of the continuous feeding method in critically ill patients, compared with the intermittent feeding method. - Prospective, randomized controlled study - Primary outcome: the achievement rate of target nutritional goal within 7 days after the start of enteral nutrition - Secondary outcome: gastrointestinal tolerance, In-ICU/hospital mortality, frequency of hospital-acquired infection, ICU/hospital length-of-stay, duration of mechanical ventilation


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - adult patient admitted in the intensive care unit - age 20 years old or more - The enteral nutritional support is expected to be available within 48 hours after ICU admission Exclusion Criteria: - previous abdominal surgery within 1 month - gastrointestinal bleeding, bowel obstruction, refractory vomiting/diarrhea - hypersensitivity to prokinetics, history of seizure or phechromocytoma - enteral feeding via enterostomy or gastrostomy - difficulty to insert or maintain nasogastric tube - need for specialized feeding (ex: hemodialysis diet, chronic renal failure diet, diabetes diet) - pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Continuous enteral feeding via infusion pump

Intermittent enteral feeding via gravity-based infusion


Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Daehak-ro, Jongno-gu

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Achievement rate of target nutritional goal Within 7 days after the start of enteral feeding
Secondary Gastrointestinal tolerance Within 7 days after start of enteral feeding
Secondary ICU/hospital mortality During hospital admission
Secondary Frequency of hospital-aquired infection During hospital admission
Secondary ICU/hospital length-of-stay During hospital admission
Secondary Duration of mechanical ventilation During hospital admission
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